December 5, 2024

Deviations: Understanding OOS, OOT, and OOE in Pharmaceutical QC Laboratories

In the pharmaceutical and life sciences industries, product quality and patient safety are paramount. But what happens when processes don’t go according to plan? Managing deviations—unexpected events that diverge from approved standard operating procedures (SOPs), guidelines, or specifications—is crucial for maintaining compliance, quality, and safety throughout manufacturing, distribution, storage, and testing.  A deviation can occur when a parameter, measurement or analytical result exceeds a defined threshold, signalling a potential risk. Addressing these issues promptly and effectively is essential to prevent […]
December 2, 2024
Lab Technician evaluation environmental monitoring data

Real-Time Environmental Monitoring: a Recent Innovation in Sterile Manufacturing

The pharmaceutical industry is undergoing a transformation, driven by the latest updates to GMP regulations like Eudralex Annex 1. This evolution demands more robust and efficient environmental monitoring solutions, particularly in the manufacturing of sterile medicinal products. One of the most promising advancements in this field is Real-Time Environmental Monitoring (RTEM), which provides continuous insights into air quality and contamination risks, ultimately enhancing compliance and operational efficiency.  The Need for Real-Time Monitoring  Traditionally, environmental monitoring (EM) has relied on growth-based methods, […]
November 28, 2024

Training day

This Tuesday, we had an engaging and insightful training day at Trevalco! Our consultants participated in a variety of sessions:Pharmaceutical Packaging led by Marleen ClynhensIT Infrastructure by Laetitia TardifEquipment Qualification and Sterilization Validation with Jolanda Muurman Our expert trainers delivered high-quality, interactive sessions that catered to both our junior and senior consultants. Their expertise and energy made the day a valuable learning experience for everyone!
November 8, 2024
Vincent junior consultant GMP

Colleague in the Spotlight – Vincent

Vincent is one of our junior consultants. Graduated Master in Biochemistry and Biotechnology, he has been working for two years as a consultant in GMP production environments. His first assignment was as project engineer on aseptic (sterile) production plants, a few months ago he started his second assignment at Trevalco as production engineer. In this short interview, we let Vincent talk about the content of his duties as a production engineer. What are your main duties as a production engineer? […]
October 24, 2024
Brent voor als validatie consultant een P&ID walkdown uit

Colleague in the Spotlight – Brent

Brent is one of our junior consultants. With three years of validation experience in GMP production environments, he has a lot of practical and theoretical knowledge about cleaning validation and sterilization validation. In this short interview, we let Brent talk about the content of his duties as a validation consultant. What are your main tasks as a validation consultant? My tasks are very diverse and in fact almost every task within the validation life cycle is equally important. As soon […]
September 30, 2024

Spartacus Run 2024

This past weekend, four enthusiastic colleagues from Trevalco tackled the AA Drink Spartacus Run in Boom, one of Belgium’s most challenging and exciting obstacle races. Set in the scenic but demanding terrain of De Schorre, this event saw participants navigate a course filled with mud, water, and tough obstacles spread across 10 km. Despite the chilly weather, spirits were high as the Trevalco team confronted obstacles such as towering climbs, muddy trenches, and even sections requiring swimming. The race, known […]
September 24, 2024

Can AI Chatbots Pass the GMP test? Insights for QA in Life Sciences

In this follow-up to our exploration of conversational AI, we dive deeper into the accuracy and effectiveness of popular AI chatbots like ChatGPT, Google Gemini, Meta AI, and Anthropic Claude when it comes to crucial QA tasks in Life Sciences. We put these AI tools to the test with tasks such as: While these chatbots show potential, particularly in tasks like pre-writing and document review, our evaluation found significant limitations—especially with fabricating information on GMP regulations. So, are AI tools […]
September 5, 2024

Unlock the Power of Conversational AI in Life Sciences QA

In today’s fast-evolving Life Sciences sector, Quality Assurance (QA) Officers face increasing pressures to manage documentation, compliance, and operational processes. Could Conversational AI be a solution to enhance efficiency and accuracy? AI chatbots like ChatGPT, Microsoft Copilot, and Google’s Gemini are revolutionizing how professionals operate. These AI tools can assist in various ways, from summarizing complex regulatory documents to brainstorming solutions, editing reports, and even automating repetitive tasks. How Can Conversational AI Help Your QA Team? However, while AI offers […]